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Tom Richards MD/MS – trichards0445@me.com Member, Board of Directors, Northwest Regional Telehealth Resource Center Emergency Department Physician, Sheridan Memorial Hospital, Sheridan Wyoming CEO, Apollo Telemedicine and MobileHealthWare Developer of the WoundMap mobile app

FDA Oversight of Medical Devices The latest – Guidance from the FDA

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•This NRTRC webinar is intended for educational purposes only. The information in this presentation and the opinions expressed are my best attempt at explaining the recently released Mobile Medical Apps Guidance from the FDA.

•You should contact the FDA directly for specific questions about how the FDA Guidance may affect specific your mobile app development.

Disclaimer

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Mobile Medical Applications Guidance for Industry and FDA Staff

Issued September 25, 2013 (Based on the 2011 draft)

http://www.fda.gov/medicaldevices/productsandmedicalprocedures/connectedhealth/mobilemedicalapplications/default.htm

FDA Oversight of Medical Devices The latest – Guidance from the FDA

Agenda

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A quick history of FDA regulation.

Overview of the FDA approval process.

What apps will the FDA not regulate?

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What apps will the FDA regulate will the FDA not regulate?

Why is the FDA choosing to regulate apps?

Specific Examples

What are mobile medical apps?

Why does the FDA want to regulate mobile medical apps?

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2008 - Apple App Store Opens

2015 - 500 Million Smartphone Users Worldwide will be using healthcare apps

2018 - 1.7 Billion smartphone and tablet users will have downloaded mobile health apps

“A reaction to exponential growth in the market” – Patel Bakul.

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• FDA dates to 1906 with the passage of the Federal Food and Drugs Act and its jurisdiction encompasses - most food products (other than meat and poultry), human and animal drugs, therapeutic agents of biological origin, medical devices, radiation-emitting products for consumer, medical, and occupational use, cosmetics, and animal feed.

FDA Oversight A very brief history

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• 1989 Draft Software Policy

• 1996 Medical Devices; Current Good Manufacturing Practice and Quality System Regulation

• 2005 withdrawl of Draft Software Policy “due to exponential growth in type and diversity of field”

• 2011 Medical Device Data Systems classification system – Class I (lower risk) to Class III (higher risk)

FDA Oversight of Medical Devices Again - A very brief history

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Mobile Medical Applications Guidance for Industry and FDA Staff

Issued September 25, 2013 (Based on the 2011 draft)

http://www.fda.gov/medicaldevices/productsandmedicalprocedures/connectedhealth/mobilemedicalapplications/default.htm

FDA Oversight of Medical Devices The latest – Guidance from the FDA

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“This guidance represents the FDA’s current thinking on the topic. It does not create or confer any rights for or on the any person and does not operate to bind the FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and reglations.” - there’s a lot of GRAY here.. And that’s a good thing. Every page has the header “Contains Nonbiding Recommendations” Guidance documents do not establish legally enforceable responsibilities… These are recommendations and suggestions – not requirements - but you may still have to apply for FDA clearance.

FDA Oversight of Medical Devices Guidance from the FDA – not black and white rules

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Software program that runs on a cell phone, tablet, or other mobile device

To be used as an accessory to a regulated medical device or to transform a mobile platform into a regulated medical device.

Depending on its intended use and percieved potential risk to consumers the MMA may or may not be regulated.

Design and Intended Use

What Makes an app a mobile medical app?

Mobile Medical

Application

Software and

accessory.

Software App

1. These apps are not defined as medical devices under section 201 (h) and are not regulated.

2. These apps may meet the definition of a medical app but pose a low enough risk to the public that the FDA will exercise enforcement discretion (ie not regulate them).

3. These apps are intended to be used as medical devices and, if they were to not function as intended, could pose a risk to patient safety. This is considered a mobile medical app and should be regulated.

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Three types of apps – regulation is determined based on risk to the public.

Most Health and Wellness Apps are not

medical devices

Lower risk medical apps

Higher risk medical

apps

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The intended use of a mobile medical app determines whether it meets the definition of a “device”. If, by labeling claims, advertising materials, or oral or written statements by manufactures or their representatives the app is “intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, in man or in other animals” then it may be considered a mobile medical app.

FDA Oversight of Medical Devices What is the app for? Intent is key!

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This oversight is platform neutral – the FDA will not regulate mobile device manufacturers or app distrubutors. The FDA oversight then is based on functionality as it conveys risk to the public through the mobile medical devices intended use. Example: LED light

FDA Oversight of Medical Devices The latest – Guidance from the FDA

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Mobile Medical App Manufacturer - Creates a mobile medical app or a software system that provides users access to the medical device function through a website subscription, software as a service, or other similar means.

FDA Oversight of Medical Devices More than just apps?

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Persons and entities NOT considered Mobile Medical App Manufacturers – General IT - customer support services, data center or cloud hosting services, wireless carriers, and providers of software development kits Individual Providers - health care providers who develop an app solely for their own use and do not label or promote the app for use by other providers and individuals

FDA Oversight of Medical Devices The latest – Guidance from the FDA

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Persons and entities NOT considered Mobile Medical App Manufacturers – customer support services, data center or cloud hosting services, wireless carriers, and providers of software development kits health care providers who develop an app solely for their own use and do not label or promote the app for use by other providers and individuals

FDA Oversight of Medical Devices The latest – Guidance from the FDA

Apps the FDA has chosen to regulate.

• Apps that are an extension of one or more medical devices by connection to such devices. – extend, control, display, store, analyze, or transmit

patient-specific medical device data. • EKG waveforms, PACS, actively monitor pts – subject to

regulations for such devices

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Apps the FDA has chosen to regulate.

• Apps that Control a Medical Device – control medical devices (BP cuff, Insulin pump) – must comply

with regulations applicable to connected medical devices

– Or Act as a secondary display (without altering or manupulating the image) – example transmits wt or BP measurements

• apps that act as a secondary display but don’t provide primary diagnosis and treatment decisions – Class I (no premarket submission necessary – general controls are adequate)

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Apps the FDA has chosen to regulate.

• Apps that – Perform patient-specific analysis (looks at a

mole and predicts melanoma) – Provide patient-specific diagnosis or

treatment recommendations • Examples include: apps that calculate medication

dose (insulin for example) or radiation dose based on patient-specific data

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Apps the FDA has chosen to regulate.

• “Apps that transform a mobile platform into a regulated medical device using attachments, display screens, or other such methods.” - example – AliveCor heart monitor

• Mobile Apps that transform the mobile platform into a regulated medical device by creating a tool similar to currently regulated medical devices. Example – Inulin Pump Controller

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If the FDA is already regulating it, they’re going to regulate it in app form.

Apps the FDA has chosen not to regulate.

• Enforcement discretion based on low risk to patients. – Self help, coaching, medication reminders – Tools to organize and track health information – Reference tools for specific conditions – Tools usdd to communicate with providers – Clinical Calculators for providers – Apps to communicate with personal health record

(PHR) or electronic health record (EHR) systems The common denominator = low risk, patient directed, self management or self directed

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Apps the FDA has chosen not to regulate.

• Some psychiatric apps – for instance that maintain or improve coping skills

Example: moodhacker – focused on self management of depression

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Apps the FDA has chosen not to regulate.

• Reminder apps for pregnancy, smoking, etc

Example: BabyBump – tracks and shares stages of pregnancy

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Apps the FDA has chosen not to regulate.

• GPS-enabled asthma management apps

Example: Propeller Health or iAsthma GPS Tracker HD – helps users understand environmental triggers for asthma attacks

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Apps the FDA has chosen not to regulate.

• Some physical therapy apps –these use video or video games to motivate patients to do exercises at home

Example: PT Pal – a home physical therapy app

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Apps the FDA has chosen not to regulate.

• Some drug interaction apps for consumers, these focus on OTC meds and herbs

Example: CVS OTC drug interaction checker

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Other apps the FDA has chosen not to regulate

• Asthma apps that track inhaler usage • Preventative screening apps • Symptom navigator apps – when to seek help,

provider locations, etc. • Medication reminder apps

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FDA Approval Process Initial steps.

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Step 1. Go to FDA.gov and look for a

predicate product

Step 2. Determine if

you need premarket submission

Step 3. Tag your app to

an existing product or apply for a new FDA

approval

THANK YOU!

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